bludigo

Generic: indigotindisulfonate sodium

Labeler: provepharm inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name bludigo
Generic Name indigotindisulfonate sodium
Labeler provepharm inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

indigotindisulfonate sodium 8 mg/mL

Manufacturer
Provepharm Inc.

Identifiers & Regulatory

Product NDC 81284-315
Product ID 81284-315_2d60b6a4-17d2-4864-b01c-9862283da8de
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216264
Listing Expiration 2026-12-31
Marketing Start 2022-09-06

Pharmacologic Class

Classes
diagnostic dye [epc] dyes [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81284315
Hyphenated Format 81284-315

Supplemental Identifiers

UPC
0381284315050
UNII
D3741U8K7L

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name bludigo (source: ndc)
Generic Name indigotindisulfonate sodium (source: ndc)
Application Number NDA216264 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 8 mg/mL
source: ndc
Packaging
  • 5 AMPULE in 1 CARTON (81284-315-05) / 5 mL in 1 AMPULE (81284-315-00)
source: ndc

Packages (1)

81284-315-05 5 AMPULE in 1 CARTON (81284-315-05) / 5 mL in 1 AMPULE (81284-315-00)

Ingredients (1)

indigotindisulfonate sodium (8 mg/mL)

Linked Drug Pages (1)

BLUDIGO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2d60b6a4-17d2-4864-b01c-9862283da8de", "openfda": {"upc": ["0381284315050"], "unii": ["D3741U8K7L"], "spl_set_id": ["73f246c4-b127-452e-856f-134b56cb8870"], "manufacturer_name": ["Provepharm Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 AMPULE in 1 CARTON (81284-315-05)  / 5 mL in 1 AMPULE (81284-315-00)", "package_ndc": "81284-315-05", "marketing_start_date": "20220906"}], "brand_name": "BLUDIGO", "product_id": "81284-315_2d60b6a4-17d2-4864-b01c-9862283da8de", "dosage_form": "INJECTION", "pharm_class": ["Diagnostic Dye [EPC]", "Dyes [MoA]"], "product_ndc": "81284-315", "generic_name": "indigotindisulfonate sodium", "labeler_name": "Provepharm Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BLUDIGO", "active_ingredients": [{"name": "INDIGOTINDISULFONATE SODIUM", "strength": "8 mg/mL"}], "application_number": "NDA216264", "marketing_category": "NDA", "marketing_start_date": "20220906", "listing_expiration_date": "20261231"}